Preclearance Procedure & Operations Helpful pointers about the submission process 1 Dannie Newman PAAB Reviewer

2 PAAB Submission Procedure New Submission/First review – General Requirements/Timelines Submitting Revisions – General Requirements/Timelines Time Savers! – Reasons for having files returned – When should files be separated/submitted as separate efiles

Efiles System Electronic submission using efiles – See for tutorialwww.paab.ca – Initial set-up: contact Glenn Golaz – All submission queries: or contact Laurie Johns, Sabrina Hack, Estelle All submissions (including references) are co nfidential 3

General Requirements for a new submission…

Cover letters Every new submission should be accompanied by a cover letter – What documents have been included in the submission – Describe how the tool will be used (i.e. rep directed or HCP driven tool) – Is it a renewal? Provide previously approved efile # – Is there pick up from previously approved efiles? – Identify any special considerations

Regulatory Requirements Product Monograph (PM) – Most current – Submission control must match on PM & Letter Health Canada approval letter – NOC, NOL NOC - Notice of Compliance, NOL - No objection Letter

Annotated PM An annotated PM highlights all additions and deletions made

Annotated PM With each new submission for the first 3 months after notifying PAAB of the change For renewals if PM updated since APS accepted PM update during an ongoing review may incur a new file # and fee Provide confirmation where relevant for the PM update approval e.g. NOL or Regulatory affairs letter to confirm (level III of IV change)

English Copy Copydeck (and/or layout) – format used for the initial submission should be maintained for the duration of the review process – finalized before submitting to PAAB Shouldn’t be any to-be-determined elements Multiple options for any copy Medical Regulatory must have signed off on piece prior to submitting – Identify previously approved copy – Reference all claims

Copydeck: Referencing Each claim or presentation should be clearly referenced. Clear identification of the reference source, page number and section of the page – Don’t just cite the source (s) (5-7) References appear in a different colour from the advertising copy

Copydeck: Referencing Clearly identify the reference source, page number and section of the page Example: Ref 1A, p. 151 Source – Ref 1 Section on the page (highlighted) - A Page # - p.151 Example: Based on efile 31223

Don’t stop here with the referencing

References The corresponding section(s) of the reference should be highlighted and labeled

References in efiles Name the file with the reference number and the title of the paper Ref 1 – Efficacy and safety of Product X

Electronic Tools Additional requirement for electronic tools (e- detail aids, apps, websites) Flow of information Include the information architecture (i.e. sitemap, storyboard)

Site Map & wireframe

Summary: New submission requirements Cover letter Product Monograph & NOC/NOL Copydeck (finalized) References Information architecture Timeline: Response from PAAB within ~10 business days.

General Requirements for submitting revisions…

Letters of response Every re-submission should be accompanied by a letter of response – actions taken in response to PAAB comments – unsolicited changes etc.

Revised Copydeck All revisions should be highlighted on the copydeck – highlighted in a different colour from unsolicited changes Only revisions and changes from the previous copydeck should be highlighted – Remove any residual highlights from previous versions of the copydeck – Where copy is removed, indicate with strikethroughs and highlighting Apply revisions throughout the piece

Not like this

Revised Copydeck Unsolicited revisions Solicited revisions (additions) Solicited revisions (deletions)

References Provide any new references Same requirements apply to revisions, new copy must be clearly referenced. Each claim or presentation should be clearly referenced. Clear identification of the reference source, page number and section of the page – Don’t just cite the source (s) (5-7) Corresponding section of the reference highlighted and labeled

Revised Copydeck

Summary: Requirements for submitting revisions Letter of response Revised copydeck References (include new references and highlight/label accordingly) Timeline: Response from PAAB within ~3 business days.

To get to approval… Clearance is conditional on compliance with all applicable PAAB codes – i.e. requested revisions have been completed French copy provided if bilingual Complete Layout required – Including any audio or animated features, video`s etc.

Timesavers: Why are files returned? Incomplete submission: Have I included all the information discussed in the “New submission/First review” section? File needs to be split into separate files: Is there more than one regulatory audience? Is information accessed through different mediums (i.e. website with s, downloadable documents)? Are there different products discussed? If in doubt, call us!